There are no data on the use of denosumab in steroid induced osteoporosis. Postmenopausal women with chronic use of Glucocorticoid (GCs) are at high-risk of osteoporotic fractures. Despite bisphosphonate treatment, a certain proportion of high-risk patients using chronic GCs either do not achieve a satisfactory gain in bone mineral density (BMD) or develop new fragility fractures. Thus, more potent osteoporosis treatment is necessary for this subgroup of patients. This prompts the current study which aims to examine the efficacy of denosumab in current users of oral bisphosphonates for Glucocorticoid-induced Osteoporosis (GIOP).

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Women or adult men (>18 years of age) with various medical diseases requiring long-term prednisolone treatment. Pre-menopausal women should have no plan for pregnancy within 2 years of study entry and agree to practice contraception during this 2-year period.

A daily dose of prednisolone (or equivalent) of more than 2.5mg within 3 months of study entry.

Having received oral bisphosphonate treatment for at least 2 years.

Suboptimal response to bisphosphonate treatment, defined as either one of the following: (1) failure of lumbar spine, femoral neck or total hip BMD values to increase; (2) values of lumbar spine, femoral neck or total hip BMD remain osteoporotic, ie. T scores < -2.5 or Z scores < -2.0; or (3) development of new fragility vertebral or non-vertebral fractures despite at least 2 years' treatment with good compliance.

Informed consent from patients.

Exclusion Criteria:

Patients with previous use of denosumab or teriparatide.

Premenopausal women who plan for pregnancy within 2 years of study entry or who do not agree for contraception within this 2-year period.

Patients with known bone disorders such as osteomalacia, renal osteodystrophy, and hyperparathyroidism.

Patients with unexplained hypocalcemia.

Patients with serum creatinine level of >=200umol/L.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01465568